Carmen Polanco Lazo
Senior Strategic Advisor – Quality & Compliance
Quality
Executive Summary
Senior pharmaceutical quality and compliance architect with over 30 years of experience ensuring regulatory integrity, operational excellence, and risk governance across global manufacturing networks. Recognized for translating complex GMP and regulatory frameworks into scalable, execution-ready systems that safeguard product quality and enable sustainable patient access.
Thera Contribution
As Quality & Compliance Architect at Thera Health Policy & Access, Carmen anchors the firm’s capability to translate strategy into compliant, executable, and trusted solutions.
She is a critical driver of Thera’s Deliver → Demonstrate phases, ensuring that market access and policy strategies are operationalized within robust quality systems, regulatory frameworks, and risk management models.
Her role ensures that what Thera designs is not only strategic and innovative, but also:
- Regulator-ready
- Inspection-resilient
- Operationally sustainable
By integrating GMP rigor with system-level execution, she strengthens Thera’s positioning as a platform that transforms complexity into real-world, trusted outcomes.
Executive Profile
Carmen Polanco is a senior pharmaceutical quality and compliance leader with more than 25 years of experience across GMP systems, global manufacturing oversight, and regulatory governance.
She is widely recognized for her ability to architect quality systems that bridge scientific integrity, regulatory compliance, and operational execution, ensuring that products and organizations meet the highest global standards.
Her leadership is defined by a 360-degree quality perspective, combining:
- Site-level execution and manufacturing operations
- Regional compliance governance (LATAM)
- Global oversight of external manufacturing networks
This integrated experience allows her to anticipate systemic risks and design compliance frameworks that are not only technically robust but also scalable, auditable, and sustainable across diverse markets.
Areas of Strategic Impact
GMP Compliance & Quality Risk Architecture
Designs comprehensive quality systems and risk models for global manufacturing environments, translating regulatory complexity into proactive governance strategies at the executive level.
External Manufacturing & Global Supply Governance
Leads quality oversight models for external manufacturing networks, ensuring alignment with global GMP standards and securing inspection readiness and supply reliability across partners.
Operational Excellence & Site Quality Leadership
Extensive hands-on experience leading manufacturing site quality functions—from plant commissioning to sustained compliance—ensuring end-to-end product quality and operational performance.
Lifecycle Quality Integration (R&D to Commercial)
Brings a deep scientific foundation in pharmaceutical development, enabling a systems-level view of the product lifecycle that strengthens decision-making from early development through commercialization.
Professional Background
Carmen built a distinguished career over more than two decades at Teva Pharmaceuticals, where she held senior leadership roles across quality and compliance functions.
Her most recent roles include:
- Quality Compliance Director – External Manufacturing & Supply Operations (Global)
Leading global quality governance across external manufacturing networks and driving strategic improvement initiatives in Global Quality. - Quality Compliance Director – Latin America
Responsible for GMP compliance governance across multiple countries, ensuring regulatory alignment and operational consistency across the region.
Earlier in her career, she served as:
- Site Quality Head – Laboratorio Chile (Teva)
Leading QA/QC, product development, and all quality aspects of a new pharmaceutical manufacturing plant—from design and construction through commissioning and operations.
She began her career in product development and quality control, building the scientific foundation that enables her current strategic perspective.
Professional Impact & Leadership
Throughout her career, Carmen has:
- Led organizations through Health Authority inspections and compliance transformations
- Designed and implemented global quality harmonization programs
- Built frameworks that translate regulatory requirements into operational excellence
- Managed complex integration processes in multinational environments
Her work consistently ensures that organizations move from compliance as a requirement to quality as a strategic capability and competitive advantage.
Academic & Professional Credentials
- Advanced Management Program (AMP) – ESE Business School, Universidad de Los Andes (Chile)
- Postgraduate Diploma in Management – Chemical & Pharmaceutical Industries – Universidad de Chile
- Pharmaceutical Chemist – Universidad de Valparaíso
Additional Programs:
- Leadershift Executive Leadership Program – Teva Pharmaceuticals
- International Biopharmacy Courses (1–4)
